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New treatment option for Multiple Myeloma
Official title 18F-Fluciclovine PET/CT in Multiple Myeloma
ClinicalTrials.gov ID: NCT06103838
What this study is testing
What is 18F-fluciclovine injection?
18F-fluciclovine injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \>= 3...
- Anemia: Hemoglobin \<=10 g/dL, or
- Renal Failure: serum creatinine \>= 2.0 mg/dL, or
- Hypercalcemia: Ca \>= 10.5 mg/dL, or
- Lytic bone lesions on X-ray, CT, or PET/CT, or
You likely can't join if
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.
- people with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.
- Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine...
See the full eligibility criteria
- Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \>= 3 g/dL and/or bone marrow plasma cells \>= 10% and at least one of the...
- Anemia: Hemoglobin \<=10 g/dL, or
- Renal Failure: serum creatinine \>= 2.0 mg/dL, or
- Hypercalcemia: Ca \>= 10.5 mg/dL, or
- Lytic bone lesions on X-ray, CT, or PET/CT, or
- \>= 2 focal lesions on spinal MRI, or
- \>= 60% bone marrow plasma cells, or
- Involved/un-involved serum free light chain ration \>= 100
- Participants must have measurable disease defined by any one of the following:
- Monoclonal bone marrow plasma cells \> 5%
- Serum monoclonal protein \>= 0.2 g/dl
- Urine monoclonal protein \> 200 mg/24 hr
- Serum immunoglobulin free light chain \> 10 mg/dL AND abnormal kappa/lambda ratio
- A measurable lesion on PET/CT or MRI
- Participants fit criteria for one of the following categories:
- Newly diagnosed multiple myeloma (NDMM)
- Relapsed and/or refractory multiple myeloma (RRMM) with at least 1 prior line of therapy
- Age \>=18 years.
- ECOG performance status \<= 2
- Negative serum or urine pregnancy test at screening for WOCBP.
- Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine...
- Ability of subject to understand and the willingness to sign a written informed consent document.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.
- people with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.
- Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.